Asi Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Asi Medical, Inc.” (first 1994, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 181 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 412 |
| 2013 | 1 | 174 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIA | Unit, Operative Dental | 3 | 3 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| KOJ | Airbrush | 1 | 1 |
Review panels
- Dental (5)
Most recent Asi Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123139 | ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES | ELC | 2013-03-28 | 174 |
| K110481 | TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE | EIA | 2012-04-05 | 412 |
| K974488 | AIRPREP SYSTEM - MODEL 9001 | KOJ | 1998-05-26 | 181 |
| K974487 | SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 | EIA | 1998-02-18 | 84 |
| K932873 | SEAC MOBILE UNIT BY ASI MEDICAL | EIA | 1994-03-07 | 266 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-11-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Asi Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Asi Medical, Inc.” (first 1994, latest 2013), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Asi Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Asi Medical, Inc. is 181 days.
Which FDA product codes appear under Asi Medical, Inc.?
The most frequent FDA product codes under this applicant name are EIA (Unit, Operative Dental, 3); ELC (Scaler, Ultrasonic, 1); KOJ (Airbrush, 1).
Next steps
- See all 5 Asi Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIA, Asi Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.